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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Therapeutic Drug Monitoring: Drug Analysis Methods01:26

Therapeutic Drug Monitoring: Drug Analysis Methods

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood or body tissues to tailor drug therapy effectively. This monitoring is critical for managing drugs with narrow therapeutic indices like digoxin and phenytoin, ensuring they are both safe and effective. For instance, monitoring theophylline levels in asthma patients involves precision and sensitivity to adjust doses according to individual responses to therapy, ensuring efficacy and...
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Therapeutic Drug Monitoring: Overview and Classification01:16

Therapeutic Drug Monitoring: Overview and Classification

Therapeutic Drug Monitoring (TDM) is a clinical practice that measures specific drug levels in a patient's blood at designated intervals to ensure the drug concentration stays within a therapeutic range. This monitoring is crucial for optimizing individual dosage regimens, enhancing therapeutic efficacy, and minimizing drug-related toxicity. TDM is vital for drugs with narrow therapeutic windows, significant variability in pharmacokinetics, and a clear correlation between plasma levels and...

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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

Post-approval drug safety surveillance.

Robert D Gibbons1, Anup K Amatya, C Hendricks Brown

  • 1Center for Health Statistics, University of Illinois at Chicago, Chicago, Illinois 60612, USA. rdgib@uic.edu

Annual Review of Public Health
|January 15, 2010
PubMed
Summary

Detecting rare adverse drug reactions is challenging due to limited clinical trial data. This review explores methods like spontaneous reports and meta-analyses to identify drug safety signals and assess risks, such as antidepressant-related suicidality.

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High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
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Published on: July 3, 2015

Area of Science:

  • Pharmacovigilance
  • Drug Safety Research
  • Public Health

Background:

  • Post-market drug safety surveillance is crucial as clinical trials often lack sufficient power to detect rare adverse events.
  • Identifying potentially harmful effects of new and existing pharmaceuticals is a public health priority.
  • Current data and methodologies may be insufficient for timely detection of adverse drug reactions.

Purpose of the Study:

  • To review various methodologies for identifying adverse drug reactions.
  • To examine experimental design and analytical challenges in drug safety signal detection.
  • To illustrate these methods using the example of antidepressants and suicidality risk.

Main Methods:

  • Spontaneous reporting systems
  • Meta-analysis of randomized controlled trials
  • Ecological studies
  • Analysis of medical claims data

Main Results:

  • The review examines the strengths and limitations of different approaches to detecting adverse drug reactions.
  • Methodologies are discussed in the context of challenges in experimental design and data analysis.
  • Application to antidepressant data highlights the complexities of establishing drug-related risks.

Conclusions:

  • Multiple data sources and analytical methods are necessary for robust adverse drug reaction detection.
  • Addressing design and analysis limitations is key to improving timely identification of drug safety signals.
  • Further research is needed to enhance the reliability of pharmacovigilance efforts.